ISO 15814-1999 外科植入物.聚合交脂基共聚物及混料.体外降解试验

标准号：ISO 15814-1999
中文标准名称：外科植入物.聚合交脂基共聚物及混料.体外降解试验
英文标准名称：Implants for surgery - Copolymers and blends based on polylactide - In vitro degradation testing
标准类型：C45
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.40
适用范围：This International Standard is applicable to copolymers and/or blends based on polylactide, in bulk or processed forms, used for the manufacture of surgical implants. This International Standard describes methods for the determination of chemical and mechanical changes in the properties of these copolymers and/or blends under in vitro degradation testing conditions. The test methods specified in this International Standard are intended to determine the degradation rate and the changes in material properties of polylactide-based copolymers and/or blends with various comonomers (for example glycolid, trimethylene carbonate, ε-caprolactone) in vitro. These in vitro methods cannot be used to predict definitely the behaviour of these materials under in vivo conditions. The purpose of this International Standard is to compare and/or evaluate materials or processing conditions.